FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer

Sponsor

Simcere Pharmaceutical Co., Ltd (Other)

Overall Status

Unknown status

CT.gov ID

NCT00813137

Collaborator

The Affiliated Changzhou Tumor Hospital of Suzhou University (Other)

120

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

FOLFOX4 plus Avastin has been suggested as firstline regimen for advanced colorectal cancer by NCCN, a new angiogenesis inhibitor, known as Endostar(Recombinant Human Endostatin), prolonged the overall survival, time to progression and improved response rate in metastatic lung cancer in a large phase III clinical trial in china, so we design this trial to evaluate the safty and efficacy of FolFox4 plus Endostar in patients with advanced colorectal cancer

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms	Drug: Folfox4 plus recombinant human endostatin (Endostar)	Phase 2

Detailed Description

Endostar is free supported by Shangdong Simcere Medgene biotech co.,Ltd. Endostar combination with Chemotherapy has been the first line treatment regimen to advanced NSCLC. Clinical data proved that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. China NCCN colon or rectal cancer clinical practice guideline recommends Chemotherapy plus angiogenesis inhibitor as the first line treatment scheme. So we design FOLFOX4 plus Endostar to treat advanced colorectal cancer to research the RR and safety. We believe this treatment regimen may be a new approach to the advanced colorectal cancer patients.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multi-center Study of Folfox4 Combined With Recombinant Human Endostatin(Endostar)in Advanced Colorectal Cancer

Study Start Date :

Oct 1, 2008

Anticipated Primary Completion Date :

Oct 1, 2010

Anticipated Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Folfox4 plus Endostar	Drug: Folfox4 plus recombinant human endostatin (Endostar) Endostar 15mg iv drip D1~7, D15~21, Oxaliplatin 85mg/m2 iv drip D1,15, CF 200mg/m2 iv drip D1,2,15,16, 5-Fu 400mg/m2 iv D1,2,15,16, 5-Fu 600mg/m2 civ D1,2,15,16 Other Names: endostar Folfox4 L-OHP CF 5-Fu

Arm

Intervention/Treatment

Experimental: Folfox4 plus Endostar

Drug: Folfox4 plus recombinant human endostatin (Endostar)

Endostar 15mg iv drip D1~7, D15~21, Oxaliplatin 85mg/m2 iv drip D1,15, CF 200mg/m2 iv drip D1,2,15,16, 5-Fu 400mg/m2 iv D1,2,15,16, 5-Fu 600mg/m2 civ D1,2,15,16

Other Names:

endostar

Folfox4

L-OHP

5-Fu

Outcome Measures

Primary Outcome Measures

Time to progression [every two cycles]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with histologically or cytologically confirmed metastatic CRC
Measurable disease according to Response Criteria In Solid Tumours (RECIST)
Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
Age 18~75
Life expectancy > 3 months
Signed informed consent (IC)
Adequate haematological and biological functions

Exclusion Criteria:

Pregnant or lactating women
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs
Neuropathy, brain, or leptomeningeal involvement
Treatment with any biologic, cytotoxic, radiation , or hormonal therapy within four weeks.
Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
Uncontrolled significant comorbid conditions and previous radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Affiliated Changzhou Tumor Hospital of Suzhou University	Changzhou	Jiangsu	China	213000
2	The Affiliated Zhongda Hospital of Southeast University	Nanjing	Jiangsu	China